2019-01915. The National Healthcare Safety Network's Outpatient Procedure Component (OPC) Surveillance Protocol and the Bloodstream Infection (BSI) Surveillance Protocol; Request for Information

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Request for information.

SUMMARY:

The Centers for Disease Control and Prevention, in the Department of Health and Human Services, seeks information related to the surveillance protocols for the National Healthcare Safety Network's (NHSN) Outpatient Procedure Component (OPC) and Bloodstream Infection (BSI) Module of the Patient Safety Component. CDC is opening this docket to provide the opportunity to identify issues and areas for potential improvement for consideration as CDC updates and maintains the NHSN surveillance protocols beginning in 2020.

DATES:

Written comments will be accepted beginning February 14, 2019 and must be received on or before April 15, 2019.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2018-xxxx, by either of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Katherine Allen-Bridson, National Center for Emerging and Infectious Zoonotic Disease, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mail Stop H16-3, Atlanta, GA 30329.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov,, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Katherine Allen-Bridson, RN, BSN, MScPH, CIC, National Center for Emerging and Infectious Zoonotic Disease, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mail Stop H16-3, Atlanta, GA 30329. Phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Purpose of the Notice: The purpose of this notice is to request input and information from individuals and organizations on issues and areas for potential improvement for consideration as CDC updates and maintains the NHSN surveillance protocols for 2020. CDC will carefully consider all comments with an intent to improve on and maintain the requirements for a successful surveillance program: Acceptable data collection burden, consistency, sensitivity, specificity, representativeness, and timeliness. The CDC reserves the right to respond to time-sensitive issues outside of this RFI as needed to maintain the reliability of the NHSN data.

Scope of Issue: The mission of CDC's Division of Healthcare Quality Promotion (DHQP) is to protect patients and healthcare personnel and promote safety, quality, and value in national and international healthcare delivery systems. In accordance with this mission, DHQP seeks to identify effective prevention methods, foster their implementation, and measure their impact on the incidence of healthcare-associated infections (HAIs). Over 21,000 healthcare facilities report data on HAIs to CDC's NHSN. This includes data that CDC reports to the Centers for Medicare and Medicaid Services (CMS) on behalf of healthcare facilities. CMS uses the data in its public reporting and payment programs.

Approach: CDC seeks information from NHSN users and stakeholders regarding the NHSN surveillance protocols, including comments that describe specific concerns about and recommendations for specific changes regarding the following topics: Protocol scope, definitions, criteria, data collection requirements, and other surveillance specifications for the OPC and BSI module.

Also, CDC is exploring the possibility of adding a new HAI event to its surveillance protocols, hospital onset bacteremia (HOB). The scope of HOB's surveillance would be all bloodstream infections that develop in patients following hospital admission, i.e., those bloodstream infections that are not present on admission. Although this scope would be wider than Central Line-associated Bloodstream Infection (CLABSI) surveillance, CLABSI surveillance could be incorporated as a subset of HOB surveillance. CDC seeks input on NHSN's current CLABSI surveillance protocol and potential work on HOB surveillance.

Potential Areas of Focus: CDC is interested in receiving information on issues and areas for potential improvement for consideration for the following:

1. Outpatient Procedure Component surveillance protocol.

2. Patient Safety Component Bloodstream Infection Module surveillance protocol.

3. Possible addition of hospital onset bacteremia (HOB) to NHSN's surveillance protocols.

Examples of the types of information valuable to CDC include:

1. How could the CLABSI and OPC surveillance protocols and/or surveillance definitions be improved?

2. What challenges are faced when applying these definitions? What could be added to the definitions to address these challenges?

3. What protocol or data analysis changes could make the CLABSI or OPC data more useful?

Dated: February 6, 2019.

Sandra Cashman,

Executive Secretary, Centers for Disease Control and Prevention.